title: The effectiveness of problem solving therapy for stroke patients: study protocol for a pragmatic randomized controlled trial.
abstract: BACKGROUND
  Coping style is one of the determinants of health-related quality of life after stroke. Stroke patients make less use of active problem-oriented coping styles than other brain damaged patients. Coping styles can be influenced by means of intervention. The primary aim of this study is to investigate if Problem Solving Therapy is an effective group intervention for improving coping style and health-related quality of life in stroke patients. The secondary aim is to determine the effect of Problem Solving Therapy on depression, social participation, health care consumption, and to determine the cost-effectiveness of the intervention.
  
  
  METHODS
  We strive to include 200 stroke patients in the outpatient phase of rehabilitation treatment, using a multicenter pragmatic randomized controlled trial with one year follow-up. Patients in the intervention group will receive Problem Solving Therapy in addition to the standard rehabilitation program. The intervention will be provided in an open group design, with a continuous flow of patients. Primary outcome measures are coping style and health-related quality of life. Secondary outcome measures are depression, social participation, health care consumption, and the cost-effectiveness of the intervention.
  
  
  CONCLUSIONS
  We designed our study as close to the implementation in practice as possible, using a pragmatic randomized trial and open group design, to represent a realistic estimate of the effectiveness of the intervention. If effective, Problem Solving Therapy is an inexpensive, deliverable and sustainable group intervention for stroke rehabilitation programs.
  
  
  BACKGROUND
  Nederlands Trial Register, NTR2509.
authors.affiliation: Department of Rehabilitation Medicine, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands. mvisser@rijndam.nl
authors.forename: Marieke M
authors.initials: MM
authors.lastname: Visser
authors.forename: Majanka H
authors.initials: MH
authors.lastname: Heijenbrok-Kal
authors.forename: Adriaan
authors.initials: A
authors.lastname: van 't Spijker
authors.forename: Gerard M
authors.initials: GM
authors.lastname: Ribbers
authors.forename: Jan J V
authors.initials: JJ
authors.lastname: Busschbach
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D000368:Aged; D015928:Cognitive Behavioral Therapy / Q000191:economics* / Q000379:methods*; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011340:Problem Solving; D011788:Quality of Life; D020521:Stroke / Q000191:economics / Q000523:psychology; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome; D055815:Young Adult